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    Clinical Trial Results:
    A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus

    Summary
    EudraCT number
    2014-002184-14
    Trial protocol
    ES   DE   HU   IT   NL  
    Global end of trial date
    26 Oct 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Nov 2018
    First version publication date
    10 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM128-027
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02265744
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Oct 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary study objective was to compare the proportion of patients who achieved BICLA response (BICLA response rate) at Day 169 following 24-week treatment with BMS-931699 or placebo administered on a stable background therapy.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 53
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Colombia: 8
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Argentina: 20
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Taiwan: 9
    Country: Number of subjects enrolled
    Chile: 17
    Country: Number of subjects enrolled
    Poland: 14
    Country: Number of subjects enrolled
    Brazil: 58
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    South Africa: 15
    Country: Number of subjects enrolled
    Peru: 25
    Country: Number of subjects enrolled
    Mexico: 62
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Japan: 25
    Country: Number of subjects enrolled
    Russian Federation: 5
    Worldwide total number of subjects
    346
    EEA total number of subjects
    38
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    336
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    730 participants were enrolled and 349 were randomized. 3 were randomized but not treated.Of the 381 who were not randomized,3 had an adverse event, 16 withdrew consent, 1 was lost to follow-up, 339 did not meet study entry criteria and 22 due to other reasons.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Experimental:12.5mg SC BMS-931699 Weekly
    Arm description
    12.5mg subcutaneous (SC) injection Weekly dosing
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-931699
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    12.5mg subcutaneous (SC) injection Weekly dosing

    Arm title
    Experimental:12.5mg SC BMS-931699 Every other Week
    Arm description
    12.5mg SC injection Every other Week dosing
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-931699
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    12.5mg SC injection Every other Week dosing

    Arm title
    Experimental: 5mg SC BMS-931699 Every other Week
    Arm description
    5mg SC injection Every other Week dosing
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-931699
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    5mg SC injection Every other Week dosing

    Arm title
    Experimental: 1.25mg SC BMS-931699 Every other Week
    Arm description
    1.25mg SC injection Every other Week dosing
    Arm type
    Experimental

    Investigational medicinal product name
    5mg SC injection Every other Week dosing
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.25mg SC injection Every other Week dosing

    Arm title
    Placebo Comparator: 0mg SC BMS-931699 Weekly
    Arm description
    0mg SC injection Weekly dosing
    Arm type
    Placebo

    Investigational medicinal product name
    BMS-391699 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0mg SC injection weekly dosing

    Number of subjects in period 1
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Started
    69
    68
    68
    70
    71
    Completed
    49
    53
    51
    47
    58
    Not completed
    20
    15
    17
    23
    13
         Reason not provided by investigator
    1
    -
    -
    2
    -
         Adverse event, serious fatal
    -
    -
    -
    2
    -
         Consent withdrawn by subject
    2
    -
    -
    2
    -
         Adverse event, non-fatal
    8
    4
    9
    8
    2
         Participant request to discontinue
    2
    2
    2
    -
    -
         Pregnancy
    1
    2
    1
    1
    -
         Poor/Non-compliance
    1
    1
    -
    -
    2
         Lost to follow-up
    -
    -
    -
    1
    -
         Subject no longer meets study criteria
    -
    -
    -
    -
    1
         Lack of efficacy
    2
    4
    3
    4
    5
         Administrative reason by sponsor
    3
    2
    2
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental:12.5mg SC BMS-931699 Weekly
    Reporting group description
    12.5mg subcutaneous (SC) injection Weekly dosing

    Reporting group title
    Experimental:12.5mg SC BMS-931699 Every other Week
    Reporting group description
    12.5mg SC injection Every other Week dosing

    Reporting group title
    Experimental: 5mg SC BMS-931699 Every other Week
    Reporting group description
    5mg SC injection Every other Week dosing

    Reporting group title
    Experimental: 1.25mg SC BMS-931699 Every other Week
    Reporting group description
    1.25mg SC injection Every other Week dosing

    Reporting group title
    Placebo Comparator: 0mg SC BMS-931699 Weekly
    Reporting group description
    0mg SC injection Weekly dosing

    Reporting group values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly Total
    Number of subjects
    69 68 68 70 71 346
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0
        Adults (18-64 years)
    69 67 64 68 68 336
        From 65-84 years
    0 1 4 2 3 10
        85 years and over
    0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (full range (min-max))
    41.0 (18 to 64) 39.1 (19 to 68) 41.9 (19 to 69) 38.0 (19 to 69) 40.6 (18 to 68) -
    Sex: Female, Male
    Units: Subjects
        Female
    67 66 65 66 65 329
        Male
    2 2 3 4 6 17
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 1 1 0 2
        Asian
    9 7 10 9 8 43
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0
        Black or African American
    6 9 7 7 12 41
        White
    38 46 41 43 41 209
        More than one race
    0 0 0 0 0 0
        Unknown or Not Reported
    16 6 9 10 10 51
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    3 2 3 6 3 17
        Not Hispanic or Latino
    6 9 9 7 5 36
        Unknown or Not Reported
    60 57 56 57 63 293

    End points

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    End points reporting groups
    Reporting group title
    Experimental:12.5mg SC BMS-931699 Weekly
    Reporting group description
    12.5mg subcutaneous (SC) injection Weekly dosing

    Reporting group title
    Experimental:12.5mg SC BMS-931699 Every other Week
    Reporting group description
    12.5mg SC injection Every other Week dosing

    Reporting group title
    Experimental: 5mg SC BMS-931699 Every other Week
    Reporting group description
    5mg SC injection Every other Week dosing

    Reporting group title
    Experimental: 1.25mg SC BMS-931699 Every other Week
    Reporting group description
    1.25mg SC injection Every other Week dosing

    Reporting group title
    Placebo Comparator: 0mg SC BMS-931699 Weekly
    Reporting group description
    0mg SC injection Weekly dosing

    Primary: Percentage of subjects who achieve BICLA response (BICLA response rate) at Day 169.

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    End point title
    Percentage of subjects who achieve BICLA response (BICLA response rate) at Day 169.
    End point description
    BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician’s global assessment (MDGA) of disease activity (“no worsening” is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol.
    End point type
    Primary
    End point timeframe
    At Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Percentage
        number (confidence interval 90%)
    59.4 (49.7 to 69.1)
    63.2 (53.6 to 72.9)
    57.4 (47.5 to 67.2)
    58.6 (48.9 to 68.3)
    59.2 (49.6 to 68.8)
    Statistical analysis title
    P-value of Chi-sq test of 12.5mg dose Wkly vs. pbo
    Comparison groups
    Experimental:12.5mg SC BMS-931699 Weekly v Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.9745
    Method
    Chi-squared
    Confidence interval
    Statistical analysis title
    P-value of Chi-sq test of 12.5mg dose EOW vs. pbo
    Comparison groups
    Experimental:12.5mg SC BMS-931699 Every other Week v Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.6217
    Method
    Chi-squared
    Confidence interval
    Statistical analysis title
    P-value of Chi-sq test of 5mg dose EOW vs. pbo
    Comparison groups
    Experimental: 5mg SC BMS-931699 Every other Week v Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.8295
    Method
    Chi-squared
    Confidence interval
    Statistical analysis title
    P-value of Chi-sq test of 1.25mg dose EOW vs. pbo
    Comparison groups
    Placebo Comparator: 0mg SC BMS-931699 Weekly v Experimental: 1.25mg SC BMS-931699 Every other Week
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.9439
    Method
    Chi-squared
    Confidence interval

    Secondary: Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 169

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    End point title
    Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 169
    End point description
    SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(X) Response is defined as: a reduction in Day 1 SLEDAI-2K disease activity score of >= X points; no worsening of disease (defined as an increase of >= 30mm on a 100mm VAS from Day 1 as measured by the MDGA; and no new BILAG-2004 Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system scores
    End point type
    Secondary
    End point timeframe
    At Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Percentage
    number (confidence interval 90%)
        SRI (4)|
    55.1 (45.2 to 64.9)
    48.5 (38.6 to 58.5)
    39.7 (29.9 to 49.5)
    44.3 (34.5 to 54.1)
    49.3 (39.5 to 59.1)
        SRI (5)|
    37.7 (28.1 to 47.3)
    29.4 (20.3 to 38.5)
    27.9 (19.0 to 36.9)
    31.4 (22.3 to 40.6)
    33.8 (24.6 to 43.0)
        SRI (6)|
    33.8 (24.6 to 43.0)
    31.4 (22.3 to 40.6)
    27.9 (19.0 to 36.9)
    26.5 (17.7 to 35.3)
    37.7 (28.1 to 47.3)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 85

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    End point title
    Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 85
    End point description
    SRI is the Systemic Lupus Erythematosus (SLE) Responder Index; SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(X) Response is defined as: a reduction in Day 1 SLEDAI-2K disease activity score of >= X points; no worsening of disease (defined as an increase of >= 30mm on a 100mm VAS from Day 1 as measured by the MDGA; and no new BILAG-2004 Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system scores
    End point type
    Secondary
    End point timeframe
    At Day 85
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Percentage
    number (confidence interval 90%)
        SRI (4)|
    49.3 (39.4 to 59.2)
    48.5 (38.6 to 58.5)
    41.2 (31.4 to 51.0)
    47.1 (37.3 to 57.0)
    43.7 (34.0 to 53.3)
        SRI (5)|
    29.0 (20.0 to 38.0)
    32.4 (23.0 to 41.7)
    25.0 (16.4 to 33.6)
    31.4 (22.3 to 40.6)
    28.2 (19.4 to 36.9)
        SRI (6)|
    29.0 (20.0 to 38.0)
    30.9 (21.7 to 40.1)
    25.0 (16.4 to 33.6)
    31.4 (22.3 to 40.6)
    26.8 (18.1 to 35.4)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with BICLA response (BICLA response rate) at Day 85

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    End point title
    Percentage of subjects with BICLA response (BICLA response rate) at Day 85
    End point description
    BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician’s global assessment (MDGA) of disease activity (“no worsening” is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol.
    End point type
    Secondary
    End point timeframe
    At Day 85
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Percentage
        number (confidence interval 90%)
    69.6 (60.5 to 78.7)
    64.7 (55.2 to 74.2)
    57.4 (47.5 to 67.2)
    57.1 (47.4 to 66.9)
    54.9 (45.2 to 64.6)
    No statistical analyses for this end point

    Secondary: Mean change from baseline in CLASI score

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    End point title
    Mean change from baseline in CLASI score
    End point description
    Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 for CLASI activity and 0 to 70 for CLASI damage, with higher scores denoting greater disease activity or damage.
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Score
    arithmetic mean (standard deviation)
        Day 85|
    -2.31 ( 3.107 )
    -3.20 ( 4.718 )
    -1.69 ( 2.319 )
    -1.82 ( 4.515 )
    -3.11 ( 4.239 )
        Day 169|
    -3.17 ( 4.387 )
    -3.78 ( 5.555 )
    -2.47 ( 2.824 )
    -2.94 ( 4.897 )
    -3.57 ( 4.177 )
    No statistical analyses for this end point

    Secondary: Percentage of subjects with an improvement of >4 or a decrease of >50% from baseline in their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score

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    End point title
    Percentage of subjects with an improvement of >4 or a decrease of >50% from baseline in their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score
    End point description
    CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 for CLASI activity and 0 to 70 for CLASI damage, with higher scores denoting greater disease activity or damage.
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Percentage
        number (confidence interval 90%)
    39.3 (29.1 to 49.6)
    46.9 (36.6 to 57.1)
    34.5 (24.2 to 44.7)
    36.1 (26.0 to 46.2)
    42.4 (32.4 to 52.4)
    No statistical analyses for this end point

    Secondary: Change from baseline in arthritis, as assessed by American College of Rheumatology (ACR) 28-joint count of tender and swollen joints

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    End point title
    Change from baseline in arthritis, as assessed by American College of Rheumatology (ACR) 28-joint count of tender and swollen joints
    End point description
    Mean Change from Baseline Over Time; Measured by Disease Activity Score 28: A single score on a continuous scale (0–9.4). The level of RA disease activity can be interpreted as low (DAS28 <=3.2),moderate (3.2 < DAS28 <=5.1), or as high disease activity (DAS28 > 5.1)
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Disease Activity Score 28
        arithmetic mean (standard deviation)
    -4.63 ( 4.719 )
    -4.63 ( 5.311 )
    -4.75 ( 4.985 )
    -4.42 ( 5.626 )
    -3.84 ( 4.922 )
    No statistical analyses for this end point

    Secondary: Change from baseline in BILAG-2004 score of systemic lupus erythematosus (SLE) activity over time

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    End point title
    Change from baseline in BILAG-2004 score of systemic lupus erythematosus (SLE) activity over time
    End point description
    Overall British Isles Lupus Assessment Group-2004 score, BILAG Scores: A=Severe disease activity, B=Moderate disease activity, C=Mild disease, D=Inactive disease but previously affected, E=System never involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Score
    arithmetic mean (standard deviation)
        BILAG-2004 Score Day 85|
    -10.31 ( 7.480 )
    -8.83 ( 7.749 )
    -7.07 ( 7.299 )
    -8.66 ( 6.598 )
    -7.94 ( 8.008 )
        BILAG-2004 Score Day 169|
    -11.50 ( 6.983 )
    -10.46 ( 7.808 )
    -8.98 ( 6.719 )
    -9.73 ( 5.478 )
    -9.78 ( 7.590 )
    No statistical analyses for this end point

    Secondary: Cumulative corticosteroid and immunosuppressant use over time

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    End point title
    Cumulative corticosteroid and immunosuppressant use over time
    End point description
    The cumulative corticosteroids use and immunosuppressants use over time
    End point type
    Secondary
    End point timeframe
    Up to one day prior to the first dose of long-term extension period or up to 42 days post last short-term dose date, which ever is earlier
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Percentage
    number (not applicable)
        Corticosteroids: Oral|
    89.9
    82.4
    86.8
    84.3
    94.4
        Corticosteroids: Oral inhalation|
    0
    0
    1.5
    0
    0
        Immunosuppressant|
    46.4
    63.2
    38.2
    51.4
    59.2
        Immunosuppressant Azathioprine|
    23.2
    29.4
    14.7
    28.6
    33.8
        Immunosuppressant Methotrexate|
    26.1
    35.3
    25.0
    24.3
    26.8
    No statistical analyses for this end point

    Secondary: Number of subjects with Adverse Events (AEs), Serious adverse events (SAEs), and pre-established Events of Special Interest

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    End point title
    Number of subjects with Adverse Events (AEs), Serious adverse events (SAEs), and pre-established Events of Special Interest
    End point description
    Although there are no identified risks for BMS-931699, BMS has developed a list of events of special interest for the BMS-931699 program based on the known biologic class effects, the mechanism of action of BMS-931699, overall potential consequences of mmunosuppression, and preliminary data from unblinded clinical trials. Event categories of special interest for this study may include, but are not limited to: Infections, Autoimmunity, Malignancies, Injection-related reactions
    End point type
    Secondary
    End point timeframe
    On or after the first dose date of short-term study medication and up to 42 days post last short-term dose date or up to the day prior to the first dose of long-term extension period, whichever is earlier
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Serious Adverse Events|
    5
    5
    9
    8
    6
        Related SAEs|
    3
    3
    5
    0
    1
        Related Adverse Events|
    33
    30
    29
    19
    19
        AEs of Malignancies|
    0
    0
    0
    0
    0
        AEs of Infections and Infestations|
    38
    41
    35
    39
    30
        AEs Leading to Discontinuation|
    8
    5
    9
    9
    3
        Adverse Events of Autoimmunity|
    4
    0
    0
    0
    1
        Most Common Adverse Events|
    59
    56
    60
    59
    62
        Adverse Events of Local Injection Reactions|
    10
    8
    10
    3
    4
    No statistical analyses for this end point

    Secondary: Percentage of subjects with clinically significant changes in vital signs

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    End point title
    Percentage of subjects with clinically significant changes in vital signs
    End point description
    HEART RATE (BPM): HR > 100 AND CHG FROM BSL > 30 OR HR < 55 AND CHG FROM BSL < -15; SYSTOLIC BLOOD PRESSURE (MMHG) SYSBP > 140 AND CHG FROM BSL > 20 OR SYSBP < 90 AND CHG FROM BSL < -20; DIABP > 90 AND CHG FROM BSL > 10 OR DIABP < 55 AND CHG FROM BSL < -10; RESPIRATION RATE (PER MIN) RESP > 16 OR RESP CHG FROM BSL > 10; TEMPERATURE (C) TEMP > 38.3 OR TEMP CHG FROM BSL > 1.6
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Percentage
    number (not applicable)
        HEART RATE (BPM) SITTING|
    2.9
    5.9
    2.9
    2.9
    5.6
        HEART RATE (BPM) STANDING|
    4.3
    5.9
    7.4
    7.1
    5.7
        HEART RATE (BPM) SUPINE|
    0
    0
    0
    0
    0
        SYSTOLIC BLOOD PRESSURE (MMHG) SITTING|
    11.6
    17.6
    10.3
    10.0
    15.5
        SYSTOLIC BLOOD PRESSURE (MMHG) STANDING|
    14.5
    14.7
    8.8
    11.4
    20.0
        SYSTOLIC BLOOD PRESSURE (MMHG) SUPINE|
    0
    0
    0
    0
    0
        DIASTOLIC BLOOD PRESSURE (MM HG) SITTING|
    26.1
    17.6
    11.8
    17.1
    9.9
        DIASTOLIC BLOOD PRESSURE (MM HG) STANDING|
    18.8
    27.9
    25.0
    21.4
    20.0
        DIASTOLIC BLOOD PRESSURE (MM HG) SUPINE|
    0
    0
    0
    0
    0
        RESPIRATION RATE (PER MIN)|
    85.5
    82.4
    75.0
    70.0
    81.7
        TEMPERATURE (C)|
    0
    0
    1.5
    1.4
    1.4
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant electrocardiogram (ECG) abnormalities

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    End point title
    Number of subjects with clinically significant electrocardiogram (ECG) abnormalities
    End point description
    QTC Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of short-term double-blind study medication or up to the day prior to the start of long-term extension period, whichever is earlier.
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        QTC Fredericia (msec) <= 450|
    56
    58
    58
    56
    65
        QTC Fredericia (msec) 450< To <= 480|
    12
    8
    5
    11
    5
        QTC Fredericia (msec) 480 < to <= 500|
    0
    1
    2
    0
    1
        QTC Fredericia (msec) > 500|
    1
    1
    3
    3
    0
        PR Interval (msec) <= 200|
    69
    68
    64
    66
    68
        PR Interval (msec) > 200|
    0
    0
    4
    4
    3
        QRS Interval (msec) <= 120|
    68
    67
    66
    67
    70
        QRS Interval (msec) > 120|
    1
    1
    2
    3
    1
        Change from baseline in QTCF (msec) <= 30|
    66
    59
    54
    55
    62
        Change from baseline in QTCF (msec) 30 To <= 60|
    2
    7
    7
    2
    5
        Change from baseline in QTCF (msec) > 60|
    0
    2
    3
    3
    0
    No statistical analyses for this end point

    Secondary: Ctrough: Trough level serum concentration of BMS-931699 at time points specified

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    End point title
    Ctrough: Trough level serum concentration of BMS-931699 at time points specified
    End point description
    Pharmacokinetics of BMS-931699 derived from serum concentration versus time data; Pharmacokinetic Population: defined as all subjects who receive any study medication and have any available concentration-time data.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    68
    68
    68
    70
    71
    Units: ng/mL
        arithmetic mean (standard deviation)
    2040 ( 945.57 )
    640.8 ( 436.35 )
    207.1 ( 149.53 )
    62.2 ( 56.83 )
    0 ( 0 )
    No statistical analyses for this end point

    Secondary: Serum biomarkers C3, C4

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    End point title
    Serum biomarkers C3, C4
    End point description
    Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: g/L
    arithmetic mean (standard deviation)
        C3, Baseline|
    1.068 ( 0.3405 )
    1.029 ( 0.3265 )
    0.990 ( 0.3318 )
    1.028 ( 0.3149 )
    0.991 ( 0.2641 )
        C3, Day 85|
    1.037 ( 0.3024 )
    1.014 ( 0.3428 )
    1.030 ( 0.3225 )
    1.083 ( 0.3124 )
    0.986 ( 0.3005 )
        C3, Day 169|
    1.045 ( 0.3405 )
    1.010 ( 0.3557 )
    1.027 ( 0.3528 )
    1.077 ( 0.3256 )
    0.992 ( 0.2981 )
        C4, Baseline|
    0.201 ( 0.1084 )
    0.185 ( 0.1088 )
    0.177 ( 0.0861 )
    0.202 ( 0.0984 )
    0.183 ( 0.0824 )
        C4, Day 85|
    0.206 ( 0.1037 )
    0.195 ( 0.1079 )
    0.190 ( 0.0875 )
    0.215 ( 0.0965 )
    0.179 ( 0.0824 )
        C4, Day 169|
    0.212 ( 0.1161 )
    0.185 ( 0.1014 )
    0.187 ( 0.0941 )
    0.207 ( 0.0927 )
    0.184 ( 0.0896 )
    No statistical analyses for this end point

    Secondary: Serum biomarkers: Anti-Nuclear Antibodies (ANA)

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    End point title
    Serum biomarkers: Anti-Nuclear Antibodies (ANA)
    End point description
    Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169. No anti-dsDNA data was available for this report
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    66
    67
    70
    Units: Percentage
    number (not applicable)
        Baseline Negative Day 85 Negative|
    62.5
    57.1
    100.0
    50.0
    60.0
        Baseline Negative Day 85 Positive|
    37.5
    42.9
    0
    50.0
    40.0
        Baseline Positive Day 85 Negative|
    11.3
    3.4
    1
    2.0
    0
        Baseline Positive Day 85 Positive|
    88.7
    96.6
    98.2
    98.0
    100.0
        Baseline Negative Day 169 Negative|
    71.4
    33.3
    100.0
    57.1
    40.0
        Baseline Negative Day 169 Positive|
    28.6
    66.7
    0
    42.9
    60.0
        Baseline Positive Day 169 Negative|
    9.3
    2.0
    5.8
    4.3
    1.8
        Baseline Positive Day 169 Positive|
    90.7
    98.0
    94.2
    95.7
    98.2
    No statistical analyses for this end point

    Secondary: Short term: Receptor occupancy over time

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    End point title
    Short term: Receptor occupancy over time
    End point description
    Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    66
    67
    71
    Units: Percentage
    arithmetic mean (standard deviation)
        %CD4+ RO Baseline|
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        %CD4+ RO Day 85|
    95.722 ( 12.1298 )
    83.244 ( 28.9616 )
    70.520 ( 32.9107 )
    37.155 ( 31.2927 )
    0.350 ( 0.5997 )
        %CD4+ RO Day 169|
    92.390 ( 22.1377 )
    77.210 ( 29.3976 )
    74.286 ( 28.5105 )
    44.115 ( 34.3707 )
    0.334 ( 0.4460 )
        %CD8+ RO Baseline|
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        %CD8+ RO Day 85|
    95.831 ( 7.6571 )
    81.730 ( 30.4345 )
    68.960 ( 32.0543 )
    32.516 ( 29.7242 )
    0.160 ( 0.3120 )
        %CD8+ RO Day 169|
    92.043 ( 20.6963 )
    74.726 ( 33.0060 )
    69.850 ( 30.5880 )
    40.989 ( 31.9867 )
    0.235 ( 0.5438 )
    No statistical analyses for this end point

    Secondary: Percentage of subjects with BMS-931699 induced antibody response over time point specified

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    End point title
    Percentage of subjects with BMS-931699 induced antibody response over time point specified
    End point description
    Immunogenicity defined as positive for anti-drug antibodies post-baseline measurement if baseline missing or negative. If baseline is positive, then immunogenicity is defined as a positive post-baseline measurement with titer value 4 times greater than baseline. (A) all subjects with a laboratory reported positive antibody responses to BMS-931699 during the short-term double-blind treatment period are included. Overall: At least one positive sample relative to baseline during short-term double-blind and follow-up period.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    26
    34
    34
    41
    0 [1]
    Units: Percentage
    number (not applicable)
        % with Neutralizing activity|
    23.1
    41.2
    64.7
    34.1
        % with Neutralizing activity (Baseline)|
    0
    5.9
    0
    0
        % with Neutralizing activity (Overall)|
    23.1
    35.3
    64.7
    34.1
    Notes
    [1] - No BMS-931699 induced antibody response observed for placebo
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY I

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY I
    End point description
    HEMATOLOGY I: ERYTHROCYTE/PLATELET ATTRIBUTES HEMOGLOBIN HB G/L L < 0.85×PRE-RX; HEMATOCRIT HCT VOL L < 0.85×PRE-RX; PLATELET COUNT PLAT X10*9 C/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN PLATELET COUNT PLAT X10*9 C/L L < 0.85×LLN IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >= LLN OR < 0.85×PRE-RX IF PRE-RX < LLN; ERYTHROCYTES RBC X10*12 C/L L < 0.85×PRE-RX HEMATOLOGY II QUANTITATIVE WBC : LEUKOCYTES WBC X10*9 C/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF LLN <= PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; LEUKOCYTES WBC X10*9 C/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF LLN <= PRE-RX <= ULN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Erythrocytes Low|
    4
    4
    6
    3
    5
        Erythrocytes High|
    9999
    9999
    9999
    9999
    9999
        Hematocrit Low|
    6
    10
    5
    5
    8
        Hematocrit High|
    9999
    9999
    9999
    9999
    9999
        Hemoglobin Low|
    4
    4
    5
    4
    5
        Hemoglobin High|
    9999
    9999
    9999
    9999
    9999
        Platelet count low|
    1
    1
    1
    1
    2
        Platelet count high|
    0
    0
    0
    1
    0
        Quantitative WBC: Leukocytes low|
    12
    18
    12
    16
    16
        Quantitative WBC: Leukocytes high|
    1
    1
    0
    3
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY II

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY II
    End point description
    WBC DIFFERENTIAL COUNT: BASOPHILS (ABSOLUTE) BASOA X10*9 C/L H > 0.4; BLASTS (ABSOLUTE) BLASA X10*9 C/L H > 0; EOSINOPHILS (ABSOLUTE) EOSA X10*9 C/L H > 0.75; LYMPHOCYTES (ABSOLUTE) LYMPA X10*9 C/L H > 7.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10*9 C/L L < 0.75; MONOCYTES (ABSOLUTE) MONOA X10*9 C/L H > 2; NEUTROPHILS (ABSOLUTE) NEUTA X10*9 C/L L < 1.5 IF PRE-RX IS MISSING OR < 1.5 IF PRE-RX >= 1.5 OR < 0.85×PRE-RX IF PRE-RX < 1.5; COAGULATION APTT SEC H > 1.5×ULN; INTL NORMALIZED RATIO (INR) INR FRACTION H > 1.5×ULN PROTHROMBIN TIME (PT) PT SEC H > 1.5×ULN
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Basophils (Absolute) Low|
    9999
    9999
    9999
    9999
    9999
        Basophils (Absolute) High|
    0
    0
    0
    0
    0
        Blasts (Absolute) Low|
    0
    9999
    0
    0
    0
        Blasts (Absolute) High|
    0
    0
    0
    0
    0
        Eosinophils (Absolute) Low|
    9999
    9999
    9999
    9999
    9999
        Eosinophils (Absolute) High|
    3
    0
    0
    2
    1
        Lymphocytes (Absolute) Low|
    21
    29
    24
    25
    25
        Lymphocytes (Absolute) High|
    0
    0
    0
    0
    0
        Monocytes (Absolute) High|
    9999
    9999
    9999
    9999
    9999
        Monocytes (Absolute) Low|
    0
    0
    0
    0
    0
        Neutrophils (Absolute) Low|
    10
    8
    5
    7
    4
        Neutrophils (Absolute) High|
    9999
    9999
    9999
    9999
    9999
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : LIVER FUNCTION TESTS

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests : LIVER FUNCTION TESTS
    End point description
    LIVER FUNCTION TESTS:ALKALINE PHOSPHATASE (ALP) ALP U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT DBILI UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN G-GLUTAMYL TRANSFERASE (GGT) GGT U/L H > 1.15×ULN IF PRE-RX IS MISSING OR > 1.15×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN BILIRUBIN, TOTAL TBILI UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Alanine Aminotransferase Low|
    9999
    9999
    9999
    9999
    9999
        Alanine Aminotransferase High|
    12
    17
    6
    9
    8
        Alkaline Phosphatase Low|
    9999
    9999
    9999
    9999
    9999
        Alkaline Phosphatase High|
    2
    3
    2
    5
    8
        Aspartate Aminotransferase Low|
    9999
    9999
    9999
    9999
    9999
        Aspartate Aminotransferase High|
    10
    13
    11
    8
    10
        Bilirubin, Direct Low|
    9999
    9999
    9999
    9999
    9999
        Bilirubin Direct, High|
    0
    13
    0
    1
    0
        Bilirubin Total, Low|
    9999
    9999
    9999
    9999
    9999
        Bilirubin Total, High|
    0
    0
    0
    1
    1
        G-Glutamyl Transferase, Low|
    9999
    9999
    9999
    9999
    9999
        G-Glutamyl Transferase, High|
    18
    14
    16
    15
    13
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: KIDNEY FUNCTION TESTS

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests: KIDNEY FUNCTION TESTS
    End point description
    KIDNEY FUNCTION TESTS:BLOOD UREA NITROGEN BUN MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN CREATININE CREAT UMOL/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.33×PRE-RX IF PRE-RX > ULN GLOMERULAR FILTRATION RATE, CALC. (MDRD) GFRC ML/S/M*2 L < 0.8×PRE-RX; UREA UREA MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Blood Urea Nitrogen, Low|
    9999
    9999
    9999
    9999
    9999
        Blood Urea Nitrogen, High|
    9
    11
    3
    14
    10
        Creatinine, Low|
    9999
    9999
    9999
    9999
    9999
        Creatinine, High|
    2
    0
    0
    2
    1
        GLOMERULAR FILTRATION RATE, CALC. Low|
    0
    0
    0
    0
    0
        GLOMERULAR FILTRATION RATE, CALC. High|
    9999
    9999
    9999
    9999
    9999
        Urea, Low|
    9999
    9999
    9999
    9999
    9999
        Urea, High|
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests ELECTROLYTES 1

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests ELECTROLYTES 1
    End point description
    CALCIUM, TOTAL CA MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CALCIUM, TOTAL CA MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; CHLORIDE, SERUM CL MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CHLORIDE, SERUM CL MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN;
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Calcium, Total, Low|
    0
    0
    1
    0
    0
        Calcium, Total, High|
    0
    0
    0
    0
    0
        Chloride, Serum, Low|
    0
    0
    0
    0
    0
        Chloride, Serum, High|
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 2

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 2
    End point description
    BICARBONATE HCO3 MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; BICARBONATE HCO3 MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; POTASSIUM, SERUM K MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; POTASSIUM, SERUM K MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; MAGNESIUM, SERUM MG MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN MAGNESIUM, SERUM MG MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Bicarbonate, Low|
    0
    0
    0
    0
    0
        Bicarbonate, High|
    0
    0
    0
    0
    0
        Magnesium, Serum, Low|
    0
    0
    0
    0
    0
        Magnesium, Serum, High|
    0
    0
    0
    0
    0
        Potassium, Serum, Low|
    1
    0
    1
    1
    1
        Potassium, Serum, High|
    0
    0
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 3

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 3
    End point description
    SODIUM, SERUM NA MMOL/L H > 1.05×ULN IF PRE-RX IS MISSING OR > 1.05×ULN IF PRE-RX <= ULN OR > 1.05×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN SODIUM, SERUM NA MMOL/L L < 0.95×LLN IF PRE-RX IS MISSING OR < 0.95×LLN IF PRE-RX >= LLN OR < 0.95×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN PHOSPHORUS, INORGANIC PHOS MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PHOSPHORUS, INORGANIC PHOS MMOL/L L < 0.85×LLN IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >=LLN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Sodium, Serum Low|
    0
    0
    0
    0
    0
        Sodium, Serum High|
    0
    0
    0
    0
    0
        Phosphorus, Inorganic, Low|
    0
    2
    4
    1
    0
        Phosphorus, Inorganic, High|
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 1

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 1
    End point description
    GLUCOSE TESTS:GLUCOSE, FASTING SERUM GLUCF MMOL/L H > 1.3×ULN IF PRE-RX IS MISSING OR > 1.3×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN GLUCOSE, FASTING SERUM GLUCF MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; PROTEIN TESTS:ALBUMIN ALB G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN PROTEIN, TOTAL TPRO G/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PROTEIN, TOTAL TPRO G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Glucose, Fasting serum, Low|
    1
    3
    0
    4
    5
        Glucose, Fasting Serum, High|
    3
    3
    0
    0
    4
        Albumin, Low|
    1
    2
    2
    2
    1
        Albumin, High|
    0
    0
    0
    0
    0
        Protein, Total, Low|
    0
    0
    1
    1
    0
        Protein, Total, High|
    0
    0
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 2

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 2
    End point description
    OTHER CHEMISTRY TESTING LIPID TESTS: CHOLESTEROL, TOTAL (TC) CHOL MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN TRIGLYCERIDES, FASTING TRIGF MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN PANCREATIC TESTS: AMYLASE, TOTAL AMYL U/L H > 1.5×ULN; LIPASE, TOTAL (TURBIDIMETRIC ASSAY) LIPA U/L H > 1.5×ULN; LIPASE, TOTAL (COLORIMETRIC ASSAY) LIPAC U/L H > 1.5×ULN; ENDOCRINE TESTS:CORTISOL, AM CORTA NMOL/L L < 138 THYROID STIMULATING HORMONE (TSH) TSH MU/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Cholesterol, Total (TC) Low|
    9999
    9999
    9999
    9999
    9999
        Cholesterol, Total (TC) High|
    5
    4
    12
    10
    8
        Triglycerides, Fasting Low|
    9999
    9999
    9999
    9999
    9999
        Triglycerides, Fasting High|
    12
    13
    12
    10
    8
        Amylase, Total Low|
    9999
    9999
    9999
    9999
    9999
        Amylase, Total High|
    0
    0
    0
    0
    0
        Lipase, Total (Colorimetric Assay) Low|
    9999
    9999
    9999
    9999
    9999
        Lipase, Total (Colorimetric Assay) High|
    0
    0
    1
    0
    0
        Lipase, Total (Turbidimetric Assay) Low|
    9999
    9999
    9999
    9999
    9999
        Lipase, Total (Turbidimetric Assay) High|
    0
    0
    1
    0
    0
        Thyroid Stimulating Hormone, Low|
    9999
    9999
    9999
    9999
    9999
        Thyroid Stimulating Hormone, High|
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 3

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 3
    End point description
    OTHER CHEMISTRY TESTING CARDIAC TESTS: CREATINE KINASE (CK) CK U/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN; TROPONIN-I, CARDIAC SPECIFIC TROI UG/L H > ULN; METABOLITE TESTS:URIC ACID URIC MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; CHEM TEST, MULTI INDICATIONS : LACTATE DEHYDROGENASE (LD) LD U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Creatine Kinase Low|
    9999
    9999
    9999
    9999
    9999
        Creatine Kinase High|
    5
    5
    3
    3
    1
        TROPONIN-I, CARDIAC SPECIFIC Low|
    9999
    9999
    9999
    9999
    9999
        TROPONIN-I, CARDIAC SPECIFIC High|
    0
    0
    0
    0
    0
        Uric Acid, Low|
    9999
    9999
    9999
    9999
    9999
        Uric Acid, High|
    0
    0
    0
    0
    0
        Lactate dehydrogenase (LD) low|
    9999
    9999
    9999
    9999
    9999
        Lactate dehydrogenase (LD) high|
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : IMMUNOLOGY

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests : IMMUNOLOGY
    End point description
    IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H > 1.5×ULN; CRP, HIGH SENSITIVITY CRPHS MG/L H > 1.5×ULN;
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        C-Reactive Protein (CRP) Low|
    9999
    9999
    9999
    9999
    9999
        C-Reactive Protein (CRP) High|
    19
    18
    22
    18
    22
        CRP, High Sensitivity Low|
    9999
    9999
    9999
    9999
    9999
        CRP, High Senstivity High|
    0
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : URINALYSIS

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    End point title
    Number of subjects with clinically significant abnormalities in general laboratory tests : URINALYSIS
    End point description
    QUALITATIVE URINE CHEMISTRY: BLOOD, URINE UBLD N/A H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 GLUCOSE, URINE UGLU N/A H >= 1 IF PRE-RX IS MISSING OR >= 1 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 PROTEIN, URINE UPRO UNKNOWN H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 URINALYSIS II URINE WBC + RBC ; RBC, URINE URBC HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2 WBC, URINE UWBC HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2
    End point type
    Secondary
    End point timeframe
    Up to 42 days post last dose of study medication in short-term or long-term extension period
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Subjects
        Blood, Urine, Low|
    9999
    9999
    9999
    9999
    9999
        Blood, Urine, High|
    18
    21
    20
    21
    20
        Glucose, Urine, Low|
    9999
    9999
    9999
    9999
    9999
        Glucose, Urine, High|
    2
    2
    0
    0
    1
        Protein, Urine, Low|
    9999
    9999
    9999
    9999
    9999
        Protein, Urine, High|
    7
    7
    13
    7
    10
        RBC, Urine, Low|
    9999
    9999
    9999
    9999
    9999
        RBC, Urine, High|
    18
    19
    13
    17
    18
        WBC, Urine, Low|
    9999
    9999
    9999
    9999
    9999
        WBC, Urine, High|
    28
    29
    31
    31
    25
    No statistical analyses for this end point

    Secondary: Change from baseline in the SLEDAI-2K score of SLE activity over time

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    End point title
    Change from baseline in the SLEDAI-2K score of SLE activity over time
    End point description
    Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; Version 2000, also known as SLEDAI-2K. The SLEDAI-2K score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Score
    arithmetic mean (standard deviation)
        SLEDAI-2K Score Day 85
    -3.61 ( 3.345 )
    -3.24 ( 3.320 )
    -3.17 ( 3.304 )
    -4.02 ( 3.960 )
    -3.29 ( 3.953 )
        SLEDAI-2K Score Day 169
    -4.88 ( 3.370 )
    -4.17 ( 4.064 )
    -3.98 ( 3.478 )
    -4.82 ( 4.078 )
    -4.15 ( 3.728 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) over time

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    End point title
    Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) over time
    End point description
    Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) visual anlalog scale (VAS), where 0 cm = very good and 10 cm = very bad.
    End point type
    Secondary
    End point timeframe
    At Day 85 and Day 169
    End point values
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Number of subjects analysed
    69
    68
    68
    70
    71
    Units: Score
    arithmetic mean (standard deviation)
        MDGA Score Day 85
    -28.77 ( 18.193 )
    -23.87 ( 20.321 )
    -21.00 ( 20.596 )
    -20.55 ( 17.233 )
    -23.83 ( 20.752 )
        MDGA Score Day 169
    -29.30 ( 17.371 )
    -26.87 ( 21.284 )
    -28.68 ( 19.919 )
    -26.71 ( 18.182 )
    -25.28 ( 19.952 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Experimental:12.5mg SC BMS-931699 Weekly
    Reporting group description
    Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.

    Reporting group title
    Experimental:12.5mg SC BMS-931699 Every other Week
    Reporting group description
    Subjects received 1.25 mg lulizumab pegol SC injection EOW.

    Reporting group title
    Experimental: 5mg SC BMS-931699 Every other Week
    Reporting group description
    Subjects received 5 mg SC injection of lulizumab pegol EOW.

    Reporting group title
    Experimental: 1.25mg SC BMS-931699 Every other Week
    Reporting group description
    Subjects received 12.5 mg SC injection of lulizumab pegol EOW.

    Reporting group title
    Placebo Comparator: 0mg SC BMS-931699 Weekly
    Reporting group description
    Subjects received 12.5 mg SC injection of lulizumab pegol weekly.

    Serious adverse events
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 71 (8.45%)
    8 / 70 (11.43%)
    9 / 68 (13.24%)
    5 / 68 (7.35%)
    5 / 69 (7.25%)
         number of deaths (all causes)
    0
    2
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Imminent abortion
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Serum sickness
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleurisy
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Incisional hernia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Putamen haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Lupus enteritis
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Lupus nephritis
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 70 (2.86%)
    2 / 68 (2.94%)
    1 / 68 (1.47%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    3 / 71 (4.23%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Zika virus infection
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Experimental:12.5mg SC BMS-931699 Weekly Experimental:12.5mg SC BMS-931699 Every other Week Experimental: 5mg SC BMS-931699 Every other Week Experimental: 1.25mg SC BMS-931699 Every other Week Placebo Comparator: 0mg SC BMS-931699 Weekly
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 71 (87.32%)
    59 / 70 (84.29%)
    60 / 68 (88.24%)
    56 / 68 (82.35%)
    59 / 69 (85.51%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 71 (4.23%)
    5 / 70 (7.14%)
    1 / 68 (1.47%)
    3 / 68 (4.41%)
    3 / 69 (4.35%)
         occurrences all number
    4
    5
    1
    3
    3
    Headache
         subjects affected / exposed
    10 / 71 (14.08%)
    5 / 70 (7.14%)
    7 / 68 (10.29%)
    9 / 68 (13.24%)
    10 / 69 (14.49%)
         occurrences all number
    10
    5
    13
    13
    11
    Migraine
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 70 (1.43%)
    4 / 68 (5.88%)
    1 / 68 (1.47%)
    0 / 69 (0.00%)
         occurrences all number
    2
    1
    4
    1
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 71 (0.00%)
    3 / 70 (4.29%)
    3 / 68 (4.41%)
    3 / 68 (4.41%)
    5 / 69 (7.25%)
         occurrences all number
    0
    4
    3
    4
    6
    Lymphopenia
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 70 (2.86%)
    3 / 68 (4.41%)
    4 / 68 (5.88%)
    4 / 69 (5.80%)
         occurrences all number
    0
    2
    4
    6
    5
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    4 / 71 (5.63%)
    1 / 70 (1.43%)
    2 / 68 (2.94%)
    1 / 68 (1.47%)
    1 / 69 (1.45%)
         occurrences all number
    4
    1
    2
    1
    1
    Injection site pain
         subjects affected / exposed
    4 / 71 (5.63%)
    2 / 70 (2.86%)
    4 / 68 (5.88%)
    3 / 68 (4.41%)
    2 / 69 (2.90%)
         occurrences all number
    9
    27
    6
    7
    27
    Injection site reaction
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    3 / 68 (4.41%)
    2 / 68 (2.94%)
    4 / 69 (5.80%)
         occurrences all number
    0
    0
    5
    3
    7
    Pyrexia
         subjects affected / exposed
    2 / 71 (2.82%)
    4 / 70 (5.71%)
    3 / 68 (4.41%)
    1 / 68 (1.47%)
    1 / 69 (1.45%)
         occurrences all number
    2
    5
    7
    1
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    11 / 71 (15.49%)
    5 / 70 (7.14%)
    5 / 68 (7.35%)
    1 / 68 (1.47%)
    7 / 69 (10.14%)
         occurrences all number
    12
    5
    7
    1
    8
    Nausea
         subjects affected / exposed
    4 / 71 (5.63%)
    5 / 70 (7.14%)
    5 / 68 (7.35%)
    0 / 68 (0.00%)
    5 / 69 (7.25%)
         occurrences all number
    5
    8
    5
    0
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 71 (5.63%)
    2 / 70 (2.86%)
    1 / 68 (1.47%)
    3 / 68 (4.41%)
    2 / 69 (2.90%)
         occurrences all number
    4
    2
    1
    3
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 71 (5.63%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
    1 / 68 (1.47%)
    2 / 69 (2.90%)
         occurrences all number
    5
    0
    2
    1
    4
    Back pain
         subjects affected / exposed
    3 / 71 (4.23%)
    2 / 70 (2.86%)
    1 / 68 (1.47%)
    4 / 68 (5.88%)
    5 / 69 (7.25%)
         occurrences all number
    3
    3
    1
    4
    5
    Neck pain
         subjects affected / exposed
    2 / 71 (2.82%)
    4 / 70 (5.71%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    3 / 69 (4.35%)
         occurrences all number
    2
    4
    1
    0
    3
    Systemic lupus erythematosus
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 70 (1.43%)
    3 / 68 (4.41%)
    2 / 68 (2.94%)
    5 / 69 (7.25%)
         occurrences all number
    2
    1
    6
    2
    5
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 71 (4.23%)
    1 / 70 (1.43%)
    3 / 68 (4.41%)
    1 / 68 (1.47%)
    4 / 69 (5.80%)
         occurrences all number
    4
    1
    3
    1
    4
    Gastroenteritis
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
    2 / 68 (2.94%)
    3 / 68 (4.41%)
    8 / 69 (11.59%)
         occurrences all number
    1
    1
    2
    3
    8
    Influenza
         subjects affected / exposed
    2 / 71 (2.82%)
    2 / 70 (2.86%)
    3 / 68 (4.41%)
    4 / 68 (5.88%)
    0 / 69 (0.00%)
         occurrences all number
    2
    2
    3
    4
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 71 (7.04%)
    6 / 70 (8.57%)
    8 / 68 (11.76%)
    4 / 68 (5.88%)
    9 / 69 (13.04%)
         occurrences all number
    5
    8
    11
    4
    18
    Pharyngitis
         subjects affected / exposed
    4 / 71 (5.63%)
    3 / 70 (4.29%)
    7 / 68 (10.29%)
    5 / 68 (7.35%)
    2 / 69 (2.90%)
         occurrences all number
    6
    4
    8
    6
    3
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 71 (4.23%)
    9 / 70 (12.86%)
    7 / 68 (10.29%)
    3 / 68 (4.41%)
    7 / 69 (10.14%)
         occurrences all number
    3
    9
    8
    3
    7
    Urinary tract infection
         subjects affected / exposed
    4 / 71 (5.63%)
    11 / 70 (15.71%)
    9 / 68 (13.24%)
    11 / 68 (16.18%)
    6 / 69 (8.70%)
         occurrences all number
    4
    12
    10
    16
    6
    Vaginal infection
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
    5 / 68 (7.35%)
    2 / 69 (2.90%)
         occurrences all number
    1
    1
    0
    5
    2
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 71 (1.41%)
    2 / 70 (2.86%)
    4 / 68 (5.88%)
    4 / 68 (5.88%)
    4 / 69 (5.80%)
         occurrences all number
    2
    2
    4
    4
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Apr 2015
    The main purposes of this amendment are to 10 add a long term extension (LTE), 2) address regulatory requests, 3) update the generic name. In addition, editorial adjustments to provide clarification or fix typographical errors.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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